Status:
COMPLETED
Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Genomic Health
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasia...
Eligibility Criteria
Inclusion
- Subjects must be 18 years of age or older.
- Subjects must be AA or Caucasian.
- Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined.
Exclusion
- Patients of races other than AA or Caucasian.
- No tumor block available from initial diagnosis.
- No tumor or very little tumor (\<5% tumor present) in block as assessed by examination of the H\&E slide by the Genomic Health, Inc (GHI) - designated pathologist.
- Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H\&E slide by the GHI-designated pathologist.
- Insufficient RNA (\<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis.
- Failure of assay to meet pre-specified quality control (QC) specifications.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01479894
Start Date
November 1 2011
End Date
January 1 2015
Last Update
August 5 2021
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72120